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NCT03221556 · ClinicalTrials.gov registry record · NA
Improving Outcomes for Low-Income Mothers With Depression
A NA study, sponsored by Boston Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 231
- Enrollment target
NCT03221556: Completed NA study, sponsored by Boston Medical Center.
NCT03221556 is a NA study that has completed, run by Boston Medical Center. The registered enrollment target is 231 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03221556, a NA study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 231 participants
- Enrollment target
Study Summary
This is a randomized comparative effectiveness trial to improve outcomes among pregnant and post-partum women with symptoms of depression. Both interventions under study will be based in the patient-centered medical home setting at Boston Medical Center - specifically, in prenatal clinic or in the general pediatrics clinic. The study is a type 1 hybrid effectiveness-implementation trial of 230 mothers with clinically significant depressive symptomatology. Of the 230 subjects, half will receive the Engagement-Focused Care Coordination intervention; the other half will receive the Problem Solving Education intervention. Outcomes for mothers will be assessed every 2 months throughout a 12 month follow-up period. This trial is funded by a contract with PCORI, the Patient-Centered Outcomes Research Institute.
Primary Outcome
Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Interventions
- BEHAVIORAL Engagement-Focused Care Coordination (EFCC)
- BEHAVIORAL Problem Solving Education (PSE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2018-02-05 |
| Est. Completion | 2020-06-16 |
| Phase | NA |
What the finished NCT03221556 record still lists
NCT03221556 is an interventional study that assigns participants to a tested intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Engagement-Focused Care Coordination (EFCC) is the first listed.
NCT03221556 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03221556 about?
NCT03221556 is a clinical study titled "Improving Outcomes for Low-Income Mothers With Depression". This is a randomized comparative effectiveness trial to improve outcomes among pregnant and post-partum women with symptoms of depression. Both interventions under study will be based in the patient-centered medical home setting at Boston Medical Center - specifically, in prenatal clinic or in the g...
What is the current status of trial NCT03221556?
This trial is currently completed. It is a NA study. The enrollment target is 231 participants. The study started on 2018-02-05. Estimated completion is 2020-06-16.
What interventions are being tested in trial NCT03221556?
The interventions under investigation include: Engagement-Focused Care Coordination (EFCC) (BEHAVIORAL), Problem Solving Education (PSE) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03221556?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03221556's enrollment target sits among peer trials
231 465th of 2000 higher than 1,536 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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